Philips Respironics, Adulterated and Misbranded Sleep and Respiratory Devices, Pennsylvania 2024

A federal court in Pennsylvania has ordered Philips Respironics to stop manufacturing most sleep and respiratory devices at three facilities in the state until the company takes specific measures to increase the safety of its devices and ensure compliance with the Federal Food, Drug, and Cosmetic Act (FDCA).

According to a complaint filed on April 4 in the Western District of Pennsylvania, Philips Respironics, a subsidiary of Philips Holding USA Inc., violated the FDCA by manufacturing and distributing adulterated and misbranded medical devices at facilities in Murrysville and New Kensington, Pennsylvania, and remediated certain ventilators at a facility in Mt. Pleasant, Pennsylvania.

The complaint alleged that Philips Respironics failed to submit to FDA written reports of manufacturer-initiated corrections or removals for its devices, and further failed to validate and approve the process the company used to perform remediation work on certain recalled ventilators according to established procedures.

Millions of CPAP machines, BiPAP machines, and mechanical ventilators manufactured at the Murrysville and New Kensington facilities were recalled in June 2021 due to potential health risks. The recalled devices contained polyester-based polyurethane (PE-PUR) foam, which was used for sound abatement.

Defendants Philips Respironics, its parent company Philips Holding USA Inc., and subsidiary Respironics California (collectively Philips), along with Philips executives Thomas Fallon, Daniel Leonard, and Jeff DiLullo, as well as executives Roy Jakobs and Steven B. C de Baca from Philips’s Dutch parent company, agreed to resolve the complaint through a consent decree of permanent injunction.

Under the consent decree, the defendants are barred from manufacturing and distributing devices at or from the three Pennsylvania facilities unless and until Philips meets certain conditions. Those conditions include retaining an outside expert to inspect the defendants’ facilities, methods and controls to determine whether they conform to Good Manufacturing Practice regulations.

Defendant: Philips Respironics, Philips Holding USA Inc., Respironics California, Thomas Fallon, Daniel Leonard, Jeff DiLullo, Roy Jakobs, Steven B. C de Baca

Criminal Charges: Violated the Federal Food, Drug, and Cosmetic Act (FDCA) by manufacturing and distributing adulterated and misbranded medical devices

City and State: Western District of Pennsylvania

Exact Date: April 4, 2024

Sentence or Outcome: Consent decree of permanent injunction

Dollar Amounts: None

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